Medical Writing Medical Devices Value of medical writing: The regulatory writer's perspective
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Volume 31, Issue 2 - Medical Devices

Value of medical writing: The regulatory writer's perspective

Abstract

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working group developed a survey designed to gather information about the value that regulatory writers regulatory medical writers, included 25 questions, and was administered by using SurveyMonkey. A total of 548 responses were received, and 522 of the respondents were active regulatory medical writers. The survey revealed that writers felt most valued when they were consulted or had their opinion sought (n = 154, 30.8%), contributed to patients and the community (n = 89, 17.8%), and were well compensated (n = 80, 16.0%). Writers felt that their most valuable contributions to document preparation were clarity (n = 196, 44.1%) and organization (n = 80, 18%). Although most writers indicated that their employers provided sufficient opportunities for training and advancement (strongly agree, n = 131, 29%; agree, n = 197, 44.1%), writers also indicated they would benefit from additional training in leadership skills, project management, and collaborative skills/diplomacy. This insight is invaluable for shaping the future of the regulatory writing profession. 

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Barbara Grossman

Daniela Nakagawa

John Plant

Sampoorna Rappaz

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk